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Study aim
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Association between saffron supplementation and metabolic factors, serum oxidative stress indices and gene expression rate of pyroptosis related inflammatory factors in patients with type 2 diabetes
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Design
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This is a parallel, randomized, double-blind, placebo-controlled clinical trial. 60 Subjects with type 2 diabetes matched with inclusion criteria will recruit from the Clinic of Tabriz University of Medical Sciences, Tabriz, Iran.The patients will randomly assign to two groups, intervention group and control group and a code was allocated to each one of them.
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Settings and conduct
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The informed consent will obtain from participants before interview. A structured questionnaire for all the participants by face-to-face interview will completed to collect information on demographics, 24 hr food recall and physical activity level. Anthropocentric indices (weight, BMI, waist circumference, hip circumference and WHR) will measure.
The patients will randomly assign to two groups, intervention group receiving 100 mg saffron powder per day and control group consumed 100 mg of starch and dextrose per day for 8 weeks. For biochemical measurements, 10 ml venous blood samples were gathered after 12-hour overnight fasting. Statistical analysis will perform using SPSS version 13 (spssInc, Chicago, IL, USA). This study will be blind from patients and researcher.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
subjects with T2D, aged 20-60 years, BMI 25-35 kg/m2, not on insulin therapy.
Exclusion criteria:
pregnancy or lactation, subjects needed to start insulin therapy during intervention, suffering from chronic inflammatory disorders, renal or hepatic disease, smoking, any change in type or dosage of drugs, in diet or physical activity during the running period, consuming NSAIDs, steroids or hormonal drugs
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Intervention groups
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The 60 diabetic patients will randomly assign to two groups, intervention group receiving 100 mg saffron powder per day and control group consumed 100 mg of starch and dextrose per day for 8 weeks.
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Main outcome variables
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Expression rate of TLR-4, NLRP3, TXNIP, Caspase-1, IL-1β, IL-18;
Serum level of Glucose, HbA1c, Insulin, Insulin resistance and lipid profile (TG, TC, LDL, HDL);
Systolic and diastolic blood pressure, anthropocentric indices (weight, BMI, waist circumference, hip circumference and WHR);
Total antioxidant capacity, antioxidant enzymes (superoxide dismutase, glutathione peroxidase, catalase) and pro-oxidants (MDA, NO)